Trial Outcomes & Findings for Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management (NCT NCT03743415)
NCT ID: NCT03743415
Last Updated: 2023-11-29
Results Overview
Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of 16 symptoms at each weekly contact (weeks 1-12) and week 13 interview for the immediate effects. The summed symptom severity range is 0-160, a higher score reflects a worse outcome. Week 17 value of the index was analyzed to determine the sustained effects.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
908 participants
Primary outcome timeframe
Weeks 1-13 and week 17
Results posted on
2023-11-29
Participant Flow
Participants were recruited from the University of Arizona Cancer Center in Tucson and Phoenix, AZ, Valleywise Health, a federally qualified health center in Phoenix, AZ, and the community. Recruitment took place between January 16, 2019, and January 1, 2022. Research recruiters approached survivors at clinic visits, explained the study, and answered questions. Recruiters determined eligibility and followed protocol for consenting both the survivor and caregiver.
908 (N= 451 survivors, N=457 caregivers) consented. 59 caregivers dropped before baseline. 398 dyads (survivor and caregiver) were interviewed at baseline. 24 dyads were not randomized due to the following: caregivers with no survivor interview (N=15), survivor ineligible (N=2), could not be reached (N=6), and other (N=1). 374 dyads were randomized into one of two groups: Symptom Management and Survivorship Handbook (SMSH) (N=277), and Telephone Interpersonal Counseling (TIP-C) + SMSH (N=97).
Participant milestones
| Measure |
Survivors-SMSH Alone for 4 Weeks, Depression/Anxiety Responders Continued With SMSH Alone Weeks 5-12
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. After 4 weeks, depression or anxiety responders in the SMSH alone group continued with the SMSH alone for weeks 5-12. Depression or anxiety responders are survivors who started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.
|
Survivors-SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH Alone Weeks 5-12
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.
|
Survivors- SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH+TIPC Weeks 5-12
The Symptom Management and Survivorship Handbook (SMSH) is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The SMSH was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, dyads were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at week 4, and survivors who started at moderate and ended at mild. The Telephone Interpersonal Counseling (TIPC) 8-week protocol was the same for both survivor and caregiver. During weekly contact, counselors targeted social support behaviors using interpersonal communication techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. At week 13, the survivor and caregiver were each called to complete the second assessment. At week 17 they were called to complete the final assessment.
|
Survivors SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. In addition to the SMSH, each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
|
Caregivers-SMSH Alone for 4 Weeks, Depression/Anxiety Responders Continued
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. After 4 weeks, depression or anxiety responders in the SMSH alone group continued with the SMSH alone for weeks 5-12. Depression or anxiety responders are survivors who started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.
|
Caregivers-SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH Alone Weeks 5-12
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.
|
Caregivers- SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH+TIPC Weeks 5-12
The Symptom Management and Survivorship Handbook (SMSH) is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The SMSH was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, dyads were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at week 4, and survivors who started at moderate and ended at mild. The Telephone Interpersonal Counseling (TIPC) 8-week protocol was the same for both survivor and caregiver. During weekly contact, counselors targeted social support behaviors using interpersonal communication techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. At week 13, the survivor and caregiver were each called to complete the second assessment. At week 17 they were called to complete the final assessment.
|
Caregivers SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. In addition to the SMSH, each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
|
Survivor Drop-outs From SMSH Alone Prior to Week 4
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. These participants were lost to attrition prior to the week 4 assessment for response or non-response.
|
Caregiver Drop-outs From SMSH Alone Prior to Week 4
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. These participants were lost to attrition prior to the week 4 assessment for response or non-response.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
166
|
44
|
44
|
97
|
166
|
44
|
44
|
97
|
23
|
23
|
|
Overall Study
COMPLETED
|
158
|
41
|
37
|
87
|
160
|
42
|
41
|
88
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
7
|
10
|
6
|
2
|
3
|
9
|
23
|
23
|
Reasons for withdrawal
| Measure |
Survivors-SMSH Alone for 4 Weeks, Depression/Anxiety Responders Continued With SMSH Alone Weeks 5-12
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. After 4 weeks, depression or anxiety responders in the SMSH alone group continued with the SMSH alone for weeks 5-12. Depression or anxiety responders are survivors who started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.
|
Survivors-SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH Alone Weeks 5-12
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.
|
Survivors- SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH+TIPC Weeks 5-12
The Symptom Management and Survivorship Handbook (SMSH) is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The SMSH was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, dyads were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at week 4, and survivors who started at moderate and ended at mild. The Telephone Interpersonal Counseling (TIPC) 8-week protocol was the same for both survivor and caregiver. During weekly contact, counselors targeted social support behaviors using interpersonal communication techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. At week 13, the survivor and caregiver were each called to complete the second assessment. At week 17 they were called to complete the final assessment.
|
Survivors SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. In addition to the SMSH, each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
|
Caregivers-SMSH Alone for 4 Weeks, Depression/Anxiety Responders Continued
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. After 4 weeks, depression or anxiety responders in the SMSH alone group continued with the SMSH alone for weeks 5-12. Depression or anxiety responders are survivors who started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.
|
Caregivers-SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH Alone Weeks 5-12
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.
|
Caregivers- SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH+TIPC Weeks 5-12
The Symptom Management and Survivorship Handbook (SMSH) is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The SMSH was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, dyads were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at week 4, and survivors who started at moderate and ended at mild. The Telephone Interpersonal Counseling (TIPC) 8-week protocol was the same for both survivor and caregiver. During weekly contact, counselors targeted social support behaviors using interpersonal communication techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. At week 13, the survivor and caregiver were each called to complete the second assessment. At week 17 they were called to complete the final assessment.
|
Caregivers SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. In addition to the SMSH, each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
|
Survivor Drop-outs From SMSH Alone Prior to Week 4
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. These participants were lost to attrition prior to the week 4 assessment for response or non-response.
|
Caregiver Drop-outs From SMSH Alone Prior to Week 4
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. These participants were lost to attrition prior to the week 4 assessment for response or non-response.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
5
|
3
|
1
|
4
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
4
|
5
|
5
|
2
|
2
|
5
|
9
|
10
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
2
|
1
|
1
|
0
|
1
|
4
|
13
|
13
|
Baseline Characteristics
Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management
Baseline characteristics by cohort
| Measure |
Survivors-SMSH Alone for 4 Weeks, Depression/Anxiety Responders Continued With SMSH Alone Weeks 5-12
n=166 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. After 4 weeks, depression or anxiety responders in the SMSH alone group continued with the SMSH alone for weeks 5-12. Depression or anxiety responders are survivors who started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.
|
Survivors-SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH Alone Weeks 5-12
n=44 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.
|
Survivors- SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH+TIPC Weeks 5-12
n=44 Participants
The Symptom Management and Survivorship Handbook (SMSH) is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The SMSH was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, dyads were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at week 4, and survivors who started at moderate and ended at mild. The Telephone Interpersonal Counseling (TIPC) 8-week protocol was the same for both survivor and caregiver. During weekly contact, counselors targeted social support behaviors using interpersonal communication techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. At week 13, the survivor and caregiver were each called to complete the second assessment. At week 17 they were called to complete the final assessment.
|
Survivors SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12
n=97 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. In addition to the SMSH, each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
|
Caregivers- SMSH Alone for 4 Weeks, Depression/Anxiety Responders Continued w/ SMSH Alone Weeks 5-12
n=166 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. After 4 weeks, depression or anxiety responders in the SMSH alone group continued with the SMSH alone for weeks 5-12. Depression or anxiety responders are survivors who started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.
|
Caregivers-SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH Alone Weeks 5-12
n=44 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at a given time point (e.g., week 4), and survivors who started at moderate and ended at mild. At week 13, the survivor and caregiver were each called to complete the second assessment and at week 17 they were called to complete the third and final assessment.
|
Caregivers-SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH+TIPC Weeks 5-12
n=44 Participants
The Symptom Management and Survivorship Handbook (SMSH) is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The SMSH was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, dyads were referred for symptom self-management. After 4 weeks, depression or anxiety non-responders in the SMSH alone group were rerandomized (as a dyad) to either continue the SMSH alone for 8 weeks or add TIPC for 8 weeks. Depression or anxiety non-responders are survivors who do not respond to either or both depression or anxiety symptoms. Depression or anxiety responders started at severe at onset and ended at moderate or mild at week 4, and survivors who started at moderate and ended at mild. The Telephone Interpersonal Counseling (TIPC) 8-week protocol was the same for both survivor and caregiver. During weekly contact, counselors targeted social support behaviors using interpersonal communication techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. At week 13, the survivor and caregiver were each called to complete the second assessment. At week 17 they were called to complete the final assessment.
|
Caregivers- SMSH+ TIPC
n=97 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. In addition to the SMSH, each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
|
Survivor Drop-outs From SMSH Alone Prior to Week 4
n=23 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. These participants were lost to attrition prior to the week 4 assessment for response or non-response.
|
Caregiver Drop-outs From SMSH Alone Prior to Week 4
n=23 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom, and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, survivors and caregivers were referred for symptom self-management. These participants were lost to attrition prior to the week 4 assessment for response or non-response.
|
Total
n=748 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.48 years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
61.61 years
STANDARD_DEVIATION 12.28 • n=7 Participants
|
59.09 years
STANDARD_DEVIATION 13.77 • n=5 Participants
|
60.44 years
STANDARD_DEVIATION 12.47 • n=4 Participants
|
53.98 years
STANDARD_DEVIATION 16.04 • n=21 Participants
|
54.14 years
STANDARD_DEVIATION 15.56 • n=10 Participants
|
56.25 years
STANDARD_DEVIATION 16.07 • n=115 Participants
|
53.89 years
STANDARD_DEVIATION 3.46 • n=24 Participants
|
60.08 years
STANDARD_DEVIATION 14.43 • n=42 Participants
|
52.56 years
STANDARD_DEVIATION 16.52 • n=42 Participants
|
57.06 years
STANDARD_DEVIATION 13.45 • n=42 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
30 Participants
n=10 Participants
|
34 Participants
n=115 Participants
|
59 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
541 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
38 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
207 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
71 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
43 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
318 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
53 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
428 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
37 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
26 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
62 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
436 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
36 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
49 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
26 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
214 Participants
n=42 Participants
|
|
Symptom Severity
|
34.67 units on a scale
STANDARD_DEVIATION 22.28 • n=5 Participants
|
43.55 units on a scale
STANDARD_DEVIATION 23.51 • n=7 Participants
|
48.02 units on a scale
STANDARD_DEVIATION 30.12 • n=5 Participants
|
43.53 units on a scale
STANDARD_DEVIATION 22.92 • n=4 Participants
|
19.73 units on a scale
STANDARD_DEVIATION 18.00 • n=21 Participants
|
22.00 units on a scale
STANDARD_DEVIATION 18.47 • n=10 Participants
|
19.39 units on a scale
STANDARD_DEVIATION 16.31 • n=115 Participants
|
20.61 units on a scale
STANDARD_DEVIATION 17.51 • n=24 Participants
|
51.17 units on a scale
STANDARD_DEVIATION 26.01 • n=42 Participants
|
21.17 units on a scale
STANDARD_DEVIATION 23.37 • n=42 Participants
|
30.43 units on a scale
STANDARD_DEVIATION 23.72 • n=42 Participants
|
PRIMARY outcome
Timeframe: Weeks 1-13 and week 17Population: Out of 374 dyads (survivors and caregivers), 277 were randomized initially to the SMSH alone, and 97 to SMSH+TIPC.
Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of 16 symptoms at each weekly contact (weeks 1-12) and week 13 interview for the immediate effects. The summed symptom severity range is 0-160, a higher score reflects a worse outcome. Week 17 value of the index was analyzed to determine the sustained effects.
Outcome measures
| Measure |
Survivors- SMSH Alone
n=277 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. Calls lasted about 10 minutes.
Handbook: see arm/group descriptions
|
Survivors- SMSH+ TIPC
n=97 Participants
Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
TIP-C plus Handbook: see arm/group descriptions
|
Caregivers- SMSH Alone
n=277 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. The calls lasted about 10 minutes.
|
Caregivers- SMSH+ TIPC
n=97 Participants
Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
TIP-C plus Handbook: see arm/group descriptions
|
|---|---|---|---|---|
|
Symptom Severity Index- Comparison of Two Groups Created by First Randomization
Week 17
|
25.72 units on a scale
Standard Error 1.07
|
26.30 units on a scale
Standard Error 1.78
|
10.16 units on a scale
Standard Error 0.74
|
9.04 units on a scale
Standard Error 1.15
|
|
Symptom Severity Index- Comparison of Two Groups Created by First Randomization
Average over weeks 1-13
|
26.28 units on a scale
Standard Error 0.60
|
26.55 units on a scale
Standard Error 0.98
|
12.02 units on a scale
Standard Error 0.40
|
11.19 units on a scale
Standard Error 0.65
|
PRIMARY outcome
Timeframe: Weeks 5-13 and week 17Population: Survivors and caregivers randomized for the second time after survivor's non-response to the SMSH alone after 4 weeks.
Symptoms were measured using the modified General Symptom Distress Scale (GSDS), a brief instrument that measures 18 common symptoms fatigue, sleep difficulties, pain, headache, difficulty concentrating, lack of appetite, nausea, vomiting, constipation, diarrhea, numbness or tingling, skin rashes or sores, swelling, weakness, shortness of breath, cough, depression, and anxiety. Respondents indicate severity of each symptom on the scale from 0=not present to 10=worst possible. A summed symptom severity index for 16 symptoms other than depression and anxiety was computed by adding severities of 16 symptoms at each weekly contact (weeks 5-12) and week 13 interview for the immediate effects. The summed symptom severity range is 0-160, a higher score reflects a worse outcome. Week 17 value of the index was analyzed to determine the sustained effects.
Outcome measures
| Measure |
Survivors- SMSH Alone
n=44 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. Calls lasted about 10 minutes.
Handbook: see arm/group descriptions
|
Survivors- SMSH+ TIPC
n=44 Participants
Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
TIP-C plus Handbook: see arm/group descriptions
|
Caregivers- SMSH Alone
n=44 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. The calls lasted about 10 minutes.
|
Caregivers- SMSH+ TIPC
n=44 Participants
Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
TIP-C plus Handbook: see arm/group descriptions
|
|---|---|---|---|---|
|
Symptom Severity Index- Comparison of Two Groups Created by Second Randomization
Average over weeks 5-13
|
33.67 units on a scale
Standard Error 1.73
|
34.14 units on a scale
Standard Error 1.75
|
14.50 units on a scale
Standard Error 1.36
|
12.53 units on a scale
Standard Error 1.37
|
|
Symptom Severity Index- Comparison of Two Groups Created by Second Randomization
Week 17
|
37.84 units on a scale
Standard Error 2.73
|
35.86 units on a scale
Standard Error 2.82
|
15.22 units on a scale
Standard Error 1.95
|
11.92 units on a scale
Standard Error 1.96
|
SECONDARY outcome
Timeframe: Week 13 and week 17Population: Survivors and caregivers included in the first randomization
Measured using Center for Epidemiological Studies- Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms).
Outcome measures
| Measure |
Survivors- SMSH Alone
n=277 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. Calls lasted about 10 minutes.
Handbook: see arm/group descriptions
|
Survivors- SMSH+ TIPC
n=97 Participants
Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
TIP-C plus Handbook: see arm/group descriptions
|
Caregivers- SMSH Alone
n=277 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. The calls lasted about 10 minutes.
|
Caregivers- SMSH+ TIPC
n=97 Participants
Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
TIP-C plus Handbook: see arm/group descriptions
|
|---|---|---|---|---|
|
Depressive Symptoms- Comparison of Two Groups Created by First Randomization
Week 17
|
13.60 units on a scale
Standard Error 0.60
|
13.67 units on a scale
Standard Error 0.98
|
9.94 units on a scale
Standard Error 0.49
|
9.62 units on a scale
Standard Error 0.82
|
|
Depressive Symptoms- Comparison of Two Groups Created by First Randomization
Week 13
|
12.90 units on a scale
Standard Error 0.59
|
13.78 units on a scale
Standard Error 0.97
|
10.48 units on a scale
Standard Error 0.49
|
10.44 units on a scale
Standard Error 0.83
|
SECONDARY outcome
Timeframe: Week 13 and week 17Population: Survivors and caregivers randomized for the second time after survivor's non-response to the SMSH alone after 4 weeks.
Measured using Center for Epidemiological Studies- Depression (CES-D) 20-item scale. Potential score range is 0-60. Higher scores indicated worse outcome (higher depressive symptoms).
Outcome measures
| Measure |
Survivors- SMSH Alone
n=44 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. Calls lasted about 10 minutes.
Handbook: see arm/group descriptions
|
Survivors- SMSH+ TIPC
n=44 Participants
Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
TIP-C plus Handbook: see arm/group descriptions
|
Caregivers- SMSH Alone
n=44 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. The calls lasted about 10 minutes.
|
Caregivers- SMSH+ TIPC
n=44 Participants
Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
TIP-C plus Handbook: see arm/group descriptions
|
|---|---|---|---|---|
|
Depressive Symptoms- Comparison of Two Groups Created by Second Randomization
Week 13
|
19.21 units on a scale
Standard Error 1.57
|
19.17 units on a scale
Standard Error 1.65
|
11.60 units on a scale
Standard Error 1.29
|
13.60 units on a scale
Standard Error 1.29
|
|
Depressive Symptoms- Comparison of Two Groups Created by Second Randomization
Week 17
|
20.34 units on a scale
Standard Error 1.58
|
21.24 units on a scale
Standard Error 1.67
|
12.67 units on a scale
Standard Error 1.27
|
12.46 units on a scale
Standard Error 1.29
|
SECONDARY outcome
Timeframe: Week 13 and week 17Measured using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a short form. Each question is rated on a five-point scale from 1=Never to 5=Always. The lowest possible raw score is 8; the highest possible raw score is 40. Raw scores are converted into t-scores with potential range of 37.1 to 83.1. Higher scores indicate greater anxiety. The mean of the US general population is 50 with standard deviation 10. Consensus-based but not data-based thresholds for scores in cancer populations are 50 for mildly symptomatic, 60 for moderately symptomatic, and 70 for severely symptomatic.
Outcome measures
| Measure |
Survivors- SMSH Alone
n=277 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. Calls lasted about 10 minutes.
Handbook: see arm/group descriptions
|
Survivors- SMSH+ TIPC
n=97 Participants
Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
TIP-C plus Handbook: see arm/group descriptions
|
Caregivers- SMSH Alone
n=277 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. The calls lasted about 10 minutes.
|
Caregivers- SMSH+ TIPC
n=97 Participants
Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
TIP-C plus Handbook: see arm/group descriptions
|
|---|---|---|---|---|
|
Anxiety Symptoms- Comparison of Two Groups Created by First Randomization
Week 13
|
48.98 T-score
Standard Error 0.54
|
50.86 T-score
Standard Error 0.90
|
47.72 T-score
Standard Error 0.50
|
47.58 T-score
Standard Error 0.83
|
|
Anxiety Symptoms- Comparison of Two Groups Created by First Randomization
Week 17
|
49.11 T-score
Standard Error 0.54
|
50.91 T-score
Standard Error 0.90
|
47.58 T-score
Standard Error 0.50
|
46.89 T-score
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Week 13 and week 17Population: Survivors and caregivers randomized for the second time after survivor's non-response to the SMSH alone after 4 weeks.
Measured using Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety 8a short form. Each question is rated on a five-point scale from 1=Never to 5=Always. The lowest possible raw score is 8; the highest possible raw score is 40. Raw scores are converted into t-scores with potential range of 37.1 to 83.1. Higher scores indicate greater anxiety. The mean of the US general population is 50 with standard deviation 10. Consensus-based but not data-based thresholds for scores in cancer populations are 50 for mildly symptomatic, 60 for moderately symptomatic, and 70 for severely symptomatic.
Outcome measures
| Measure |
Survivors- SMSH Alone
n=44 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. Calls lasted about 10 minutes.
Handbook: see arm/group descriptions
|
Survivors- SMSH+ TIPC
n=44 Participants
Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
TIP-C plus Handbook: see arm/group descriptions
|
Caregivers- SMSH Alone
n=44 Participants
The Symptom Management and Survivorship Handbook is a self-care management handbook with each symptom chapter presented in an identical format: what the symptom is, how people describe the symptom, the causes of the symptom, strategies for managing the symptom and resources. The Handbook was available in English and Spanish. Each weekly call began with a symptom assessment. For each symptom rated at 4 or higher on a 0-10 scale of severity, the survivors were referred for symptom self-management. During weeks 2-12, Handbook use since the last call (intervention enactment) and symptoms were assessed. During weekly calls to caregivers, the caregivers were notified of symptoms above the threshold experienced by survivors and directed to the Handbook. During weeks 2-12, Handbook use and symptoms were assessed, and a summary of survivors' symptoms was provided. The calls lasted about 10 minutes.
|
Caregivers- SMSH+ TIPC
n=44 Participants
Each survivor and caregiver received one 40-minute telephone call per week for 12 weeks. The Telephone Interpersonal Counseling (TIP-C) intervention 8-week protocol was the same for both survivor and caregiver. During weekly contacts, the counselors targeted social support behaviors using interpersonal communications techniques. Counselors personalized the counseling intervention for the specific needs or interests as expressed during sessions while still adhering to a structured protocol. The final 4 weeks were Handbook only.
TIP-C plus Handbook: see arm/group descriptions
|
|---|---|---|---|---|
|
Anxiety Symptoms- Comparison of Two Groups Created by Second Randomization
Week 17
|
55.75 T-score
Standard Error 1.35
|
55.48 T-score
Standard Error 1.40
|
49.45 T-score
Standard Error 1.30
|
49.77 T-score
Standard Error 1.30
|
|
Anxiety Symptoms- Comparison of Two Groups Created by Second Randomization
Week 13
|
52.90 T-score
Standard Error 1.32
|
54.31 T-score
Standard Error 1.39
|
50.47 T-score
Standard Error 1.31
|
49.92 T-score
Standard Error 1.30
|
Adverse Events
Survivors- SMSH Alone for 4 Weeks, Depression/Anxiety Responders Continued With SMSH Alone Week 5-12
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Survivors-SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH Alone Weeks 5-12
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Survivors- SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH+TIPC Weeks 5-12
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Survivors SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Caregivers-SMSH Alone for 4 Weeks, Depression/Anxiety Responders Continued
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caregivers-SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH Alone Weeks 5-12
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caregivers- SMSH Alone for 4 Weeks, Depression/Anxiety Non-responders Continued SMSH+TIPC Weeks 5-12
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Caregivers SMSH+TIPC During Weeks 1-8 Followed by SMSH Alone During Weeks 9-12
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Survivor Drop-outs From SMSH Alone Prior to Week 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Caregiver Drop-outs From SMSH Alone Prior to Week 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Terry Badger, PhD
University of Arizona College of Nursing
Phone: 520-626-6058
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place